Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery

NCT03677310 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 2012482
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Post-operative dysphagia

  Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as "none", "mild", "moderate", and "severe".

  Change in dysphagia scores will be assessed from pre-operative baseline value to: post-operative day one value, 2 week value, 6 week value, and 12 week value.

Study Arms (2)

3% sodium chloride

EXPERIMENTAL

Subjects in this group will receive 3% sodium chloride over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.

Drug: 3% Sodium Chloride

Normal Saline

SHAM COMPARATOR

This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.

Drug: Normal Saline

Interventions

3% Sodium Chloride DRUG

3% sodium chloride will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.

3% sodium chloride

Normal Saline DRUG

Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications

You may not qualify if:

• history of cervical trauma
• baseline dysphagia
• age less than 18 years old
• history of previous anterior neck surgery
• Creatinine clearance less than 30
• Creatinine greater than 1.0
• baseline sodium greater than 145
• patients with known electrolyte abnormalities
• congestive heart failure

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Tomoko Tanaka, MD

  University of Missouri Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The bags of IV solution will be masked by the pharmacists before sending to the operating room.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is no effective treatment for post-operative dysphagia. Thus crossover is not expected.

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 19, 2018
• Study Start: April 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share